Semifluorinated alkane compositions comprising lifitegrast

Abstract

The present disclosure relates to pharmaceutical compositions comprising lifitegrast or a pharmaceutically acceptable salt thereof dissolved or suspended in a vehicle comprising a semifluorinated alkane.

Description

[0001]NVL23P02PC1 SEMIFLUORINATED^ALKANE^COMPOSITIONS COMPRISING^LIFITEGRAST Description BACKGROUND OF THE INVENTION The stability of an active pharmaceutical compound during storage over a variety of conditions is a generally of concern during development of a formulation for the compound. This aspect is especially relevant for liquid formulations of isomerizable pharmaceutically active compounds, as the isomerization processes will result in structural changes to the compound which can have significant impact on its properties, including its pharmacological properties and pharmacokinetic profile. For example, with enantiomeric compounds it may often be the case that only one of a pair of enantiomers may be active or provide a desired pharmacological effect, while the other enantiomer is less active, or even harmful. For some active drug compounds however, there may also be significant differences in physiological activity between the two enantiomers; for example one enantiomer has pharmacological activity, while the other exhibits significant drug toxicity characteristics to the extent that it may be unsafe for clinical use. Thus for drug product formulations comprising only one, or predominantly only one isomer, such as a single enantiomer of an active compound, it is not only important that the compound integrity is maintained and degradation of the compound is avoided or minimized in storage, but also that there is no loss or change in stereochemical purity of the compound in the composition. Lifitegrast is an active compound that is used for the treatment of dry eye disease (keratoconjunctivitis sicca), and is an optically active compound with one chiral stereocenter. It has the following chemical structure: The formulation of lifitegrast in the commercially available product Xiidra® is an isotonic and buffered aqueous solution, and include sodium thiosulfate as an antioxidant. The instability of lifitegrast towards oxidation was found to be a challenge in the clinical development of the investigational drug (Xiidra®), which is an aqueous ophthalmic composition comprising lifitegrast, and required the change of the formulation in the midst of the clinical phase with the addition of sodium thiosulfate as an antioxidant. The need for adding thiosulfate to overcome the instability of lifitegrast by oxidation processes was also disclosed in US11058677. Furthermore, the stability of lifitegrast under various conditions of hydrolysis (acidic, alkaline, neutral / water, oxidation, photolysis, thermal) was investigated by Kumar (Anal. Chem. Lett.12 (6) 2022, 730 – 744), which revealed that lifitegrast is highly sensitive to the alkaline degradation, sensitive to the acidic degradation and leading also to degradation in oxidative conditions. The stereocenter may have a potential to racemize, for example under acidic or basic conditions and in particular in an aqueous environment. It is thus an object of the present disclosure to provide a composition comprising lifitegrast which is, amongst other advantages, a stable composition with respect to reducing potential loss of stereochemical purity as well as general stability with regards to decreased losses or degradation of this compound, e.g. during prolonged storage, but which is also a composition which is directly applicable and suitable for therapeutic use such as for topical ophthalmic administration to the eye. For example, it may be an objective to provide a lifitegrast composition which may have improved acceptability with regards to administration and compliancy thereto by a patient with respect to a prescribed course of treatment. Further objects of the invention will be clear on the basis of the following description of the invention, examples and claims. SUMMARY OF THE INVENTION In a one aspect, the present invention provides for pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, wherein the lifitegrast is dissolved or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients; wherein the semifluorinated alkane is selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, the structural isomers of these semifluorinated alkanes or any combination thereof. The present disclosure also relates to methods for stabilizing lifitegrast in a composition, the method comprising a step of suspending lifitegrast in a liquid semifluorinated alkane. In yet a further aspect, the disclosure also provides for the use of these pharmaceutical compositions, e.g. for use as a medicine, and for use in the treatment of dry eye disease. DETAILED DESCRIPTION OF THE INVENTION In a first aspect, the present disclosure relates to a pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, wherein the lifitegrast is dissolved or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients. The semifluorinated alkane is in one embodiment, F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, the structural isomers of these semifluorinated alkanes or any combination or mixtures of these compounds. Semifluorinated alkanes are linear or branched alkanes where some of the hydrogen atoms are replaced by fluorine atoms. In one embodiment, the semifluorinated alkane (which may be abbreviated as SFAs) described and used according to the present disclosure comprises of one linear non-fluorinated hydrocarbon segment and of one linear perfluorinated hydrocarbon segment with the perfluorinated hydrocarbon segment attached to the non- fluorinated hydrocarbon segment. In a preferred embodiment, the semifluorinated alkanes used in the context of the present disclosure are preferably liquid semifluorinated alkanes. In an embodiment, the semifluorinated alkanes have the chemical formula F(CF2)n(CH2)mH, wherein n and m are integers defining the number of carbons in the perfluorinated hydrocarbon segment and non-fluorinated hydrocarbon segment respectively. In a further embodiment, the one or more semifluorinated alkanes featured in the compositions according to the present disclosure is a semifluorinated alkane of formula F(CF2)n(CH2)mH, wherein n is an integer selected from 4 to 6 and m is an integer selected from 2 to 10. In a further embodiment, the one or more semifluorinated alkanes is a semifluorinated alkane of formula F(CF2)n(CH2)mH, wherein n is an integer selected from 4 to 6 and m is an integer selected from 4 to 8. A nomenclature which is also frequently used for linear semifluorinated alkanes designates a perfluorinated hydrocarbon segment as RF and a non-fluorinated segment as RH, i.e. RFRH. Alternatively, the compounds may be referred to as FnHm, wherein F means a perfluorinated hydrocarbon segment, H means a non-fluorinated segment, and n and m define the number of carbon atoms of the respective segment. For example, F3H3 is used for perfluoropropylpropane, F(CF2)3(CH2)3H. Moreover, this type of nomenclature is usually used for compounds having linear i.e. unbranched segments. Therefore, unless otherwise indicated, it should be assumed that F3H3 means 1-perfluoropropylpropane, rather than its structural isomers e.g. branched isomers such as 2-perfluoropropylpropane, 1- perfluoroisopropylpropane or 2-perfluoroisopropylpropane. In one embodiment of the present disclosure, the vehicle may comprise of one or more semifluorinated alkanes selected from the group consisting of F4H4, F4H5, F4H6, F4H8, F6H2, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and mixtures thereof. The chemical formula of these semifluorinated alkanes may be expressed, respectively as F(CF2)4(CH2)4H, F(CF2)4(CH2)5H, F(CF2)4(CH2)6H, F(CF2)4(CH2)8H, F(CF2)6(CH2)2H, F(CF2)6(CH2)4H, F(CF2)6(CH2)6H, F(CF2)6(CH2)8H and F(CF2)6(CH2)10H. In another embodiment, the vehicle comprises a semifluorinated alkane selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, or any mixture or combination of these semifluorinated alkanes. In yet another embodiment, the vehicle consists of a semifluorinated alkane selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H10, their structural isomers, and any mixtures thereof. In yet a further embodiment, the semifluorinated alkane is F4H5 (1-perfluorobutyl-pentane), F6H8 (1-perfluorohexyl-octane), their structure isomers or any mixtures for these semifluorinated alkanes.1-perfluorobutyl-pentane, with the chemical formula F(CF2)4(CH2)5H, is an inert, water-insoluble liquid, with a density of 1.284 g / cm3at 25 °C and refractive index of 1.3204 at 20 °C. Alternative nomenclature for this compound includes F4H5, wherein F denotes a linear perfluorinated alkane segment comprising 4 carbon atoms and wherein H denotes a linear and non-fluorinated alkane segment of 5 carbon atoms. Preferably, the 1-perfluorobutyl-pentane is substantially free of water. Optionally, the formulation may comprise more than one semifluorinated alkane. It may be useful to combine semifluorinated alkanes, for example, in order to achieve a particular target property such as a certain density or viscosity. If a mixture of semifluorinated alkanes is used, it is preferred that the mixture comprises at least one of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10. In one embodiment, the vehicle comprise at least two members selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, and F6H10. In one embodiment, the vehicle comprises a combination or a mixture of 1-perfluorobutyl-pentane and 2-perfluorobutyl-pentane, optionally wherein the 2-perfluorobutyl-pentane is present in the vehicle an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w) or up to 0.2 % (w / w); or in an amount of 0.1 % to 2% (w / w), or 0.01% to 1 % (w / w) or 0.5% to 5 % (w / w) in respect total weight of the mixture of semifluorinated alkane. In yet a further embodiment, the vehicle of a composition according to the present disclosure comprises a combination, or a mixture of 1-perfluorohexyl-octane and 2-perfluorohexyl-octane, optionally wherein the 2-perfluorohexyl-octane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), up to 0.5 % (w / w), or up to 0.2 % (w / w); or in an amount of 0.1 % to 2% (w / w), or 0.01% to 1 % (w / w) or 0.5% to 5 % (w / w) in respect total weight of the mixture of semifluorinated alkane. In another embodiment, the vehicle of a composition according to the present disclosure essentially consists only of the one or more, or combination of semifluorinated alkanes as described herein. In other words, there are no further excipients such as a cosolvent (e.g. ethanol) present. For example, in one embodiment, the vehicle consists only of a semifluorinated alkane selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers and any combination or mixtures of these semifluorinated alkanes. Or in other words, the vehicle essentially consists of 100 % (w / w) of a semifluorinated alkane, or a mixture of semifluorinated alkane such as defined above. In some embodiments, the pharmaceutical composition comprises lifitegrast or a pharmaceutically acceptable salt thereof dissolved, or suspended in the semifluorinated alkane. As used herein, the term “consists” and related terms “consisting” or “consist” is to be understood as meaning that no other features, other than those prefaced by the term are present. In the context of compositions of the present disclosure, if any other constituent or component is present in the composition other than those prefaced by such term, then it is present only in trace or residual amounts such as to confer no technical advantage or relevance in respect of the object of the disclosure, such as may be further understood by the term ‘essentially” or “substantially” used in conjunction with these terms (e.g. ‘essentially consisting of”). In contrast, the term ‘comprising” or related terms “comprises” or “comprise” in the context of compositions, is to be understood as meaning that other features, other than those prefaced by the term may be present in the composition. Also as used herein, the term ‘a’ or ‘an’, or ‘the’ in relation to a semifluorinated alkane, or an excipient or any component or constituent part of the composition does not exclude the plurality unless the context clearly indicates or requires otherwise. The terms ‘a’, ‘an’ and ‘the’ may be understood to correspond to ‘at least one’ or as ‘one or more’ unless defined otherwise or unless the context clearly indicates otherwise. As understood herein, the vehicle of a composition according to the present disclosure comprises a semifluorinated alkane, or at least one semifluorinated alkane. Said vehicle may optionally however further comprise one or more excipients, as such as further described herein below. In one embodiment, the vehicle comprises more than one semifluorinated alkane. In another embodiment, the vehicle consists of one or more semifluorinated alkanes and optionally one or more pharmaceutically acceptable excipients, preferably excipients which are miscible, or soluble in the semifluorinated alkane or semifluorinated alkane mixture. In one embodiment, the amount of semifluorinated alkane or mixture of semifluorinated alkanes in the composition is in an amount of at least 90%, 95%, 96%, 97%, 98%, 99%, 99.5% or 99.8% (w / w) with respect to the total weight of the composition. In other embodiments according to the present disclosure, the pharmaceutical composition comprises from about 95 to about 99% (w / w), more preferably from about 98 to about 99% (w / w), even more preferably from about 98 to about 99.9% (w / w) of a semifluorinated alkane as based on the total weight of the composition. In an embodiment, the pharmaceutical composition comprises at least about 90%, 95%, 96%, 97%, 98%, 99% or at least 99.5% (w / w) of 1-perfluorobutyl-pentane (F4H5), and also optionally 2-perfluorobutyl- pentane, based on the total weight of the pharmaceutical composition. In a further embodiment, the pharmaceutical composition comprises at least about 90%, 95%, 96%, 97%, 98%, or at least 99% (w / w) of 1-perfluorobutyl-pentane (F4H5), and up to about 0.2%, 0.3%, 0.4%, 0.5% or up to about 1% (w / w) of 2-perfluorobutyl-pentane, based on the total weight of the pharmaceutical composition. In another embodiment, the pharmaceutical composition comprises at least about 90%, 95%, 96%, 97%, 98%, 99% or at least 99.5% (w / w) of 1-perfluorohexyl-octane (F6H8), and optionally 2-perfluorohexyl-octane, based on the total weight of the pharmaceutical composition. In a further embodiment, the pharmaceutical composition comprises at least about 90%, 95%, 96%, 97%, 98%, or at least 99% (w / w) of 1-perfluorohexyl-octane (F6H8), and up to about 0.2% , 0.3%, 0.4%, 0.5% (w / w) or up to about 1 % (w / w) of 2- perfluorohexyl-octane, based on the total weight of the pharmaceutical composition. In one embodiment, the pharmaceutical composition of the present disclosure is a solution. The term a “clear” solution, as understood herein, refers to a liquid solution in which all solutes are fully dissolvable or dissolved under room temperature conditions i.e. between 15 and 25 °C. The clear solution does not comprise of any particulate or solid phase components and preferably has a refractive index approximate to that of water (i.e.1.333) at room temperature. In one embodiment, the pharmaceutical composition according to the present disclosure comprises lifitegrast dissolved in a vehicle comprising one or more semifluorinated alkane as defined herein, and optionally, one or more excipients as defined herein, wherein the composition is in the form of a clear solution. In another one embodiment, the pharmaceutical composition according to the present disclosure comprises solid particles of lifitegrast, or solid particles comprising or essentially consisting of lifitegrast suspended in a liquid vehicle comprising one or more semifluorinated alkanes as defined herein, and optionally one or more excipients as defined herein. Or in other words, the pharmaceutical composition is in the form of a suspension. In a related embodiment, the pharmaceutical composition according to the present disclosure comprises lifitegrast suspended in a liquid semifluorinated alkane as disclosed herein. Preferably, said composition is adapted for topical ophthalmic administration. In one embodiment, the pharmaceutical composition according to the present disclosure comprises lifitegrast or a pharmaceutically acceptable salt thereof, suspended in a semifluorinated alkane, or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof. A ‘suspension’ may be defined as a type of a dispersion, a dispersion being a system having at least one continuous (or coherent) phase and at least one discontinuous (or inner) phase which is dispersed in the continuous phase. In a suspension, the dispersed phase is in the solid state. For example, and in the context of the present disclosure, a particle (i.e. in a solid state) comprising, or consisting, or essentially consisting of lifitegrast, or a pharmaceutically acceptable salt thereof may be suspended in the liquid vehicle of the composition. The suspensions useful for practising the present invention are preferably liquid suspensions, wherein the continuous phase is a liquid, i.e. the vehicle is a liquid, and moreover, the suspensions are formulated or adapted so as to be suitable administration as a medicament, or as a topically administered ophthalmic medicament. As understood herein the term ‘suspended’ or ‘suspension’ refers to a composition in which the solid phase i.e. particles are suspended or dispersed within a continuous phase. It may be the case that a suspension in resting or storage of the composition may phase separate wherein the particles flotate or sediment, but as understood herein, the suspensions as defined according to the present disclosure may be redispersible. In some embodiments, the particles of lifitegrast suspended in a semifluorinated alkane or vehicle comprising a semifluorinated alkane and optional excipient(s) as described herein has a mean diameter of less than 50 µm, or less than 30 µm, as determined by laser diffraction. In further embodiments, the mean diameter of the lifitegrast particles in a suspension formulation as described herein may be less than 20 µm, 30 μm, 15 μm, 10 μm, or less than 5 μm, as determined by laser diffraction. In other embodiments according to the present disclosure, at least 90% of the particles of lifitegrast suspended in a semifluorinated alkane or vehicle comprising a semifluorinated alkane and optional excipient(s) have a mean diameter of between 1 to 15 µm, or between 1 to 20 µm, or 1 to 30 µm, or 1 to 50 µm as determined by laser diffraction. Optionally, the particle size distribution base by which particle size of the suspension composition may be determined using laser diffraction may be volume. In such cases, ‘mean diameter’ may be understood as volume mean diameter. In an alternative embodiment, the pharmaceutical composition according to the present disclosure comprises lifitegrast dissolved in a vehicle comprising one or more semifluorinated alkane as defined herein, and optionally, one or more excipients as defined herein, wherein the vehicle comprises at least two (immiscible) liquid phases. In a related embodiment, the vehicle of the pharmaceutical composition comprises an aqueous phase, or water. This liquid aqueous phase may be in addition to another liquid phase, e.g. a liquid non-aqueous or non-aqueous miscible phase i.e. a semifluorinated alkane phase which may comprise, or consist of one or more semifluorinated alkanes and optionally, one or more excipients, such as a surfactant, as described herein. The pharmaceutical composition in such embodiments is in the form of an emulsion. An emulsion, as understood herein is a liquid system comprising a dispersed (or inner, or emulsified, or discontinuous) liquid phase within a continuous (or outer, or coherent) liquid phase. The two liquid phases are not miscible. In an o / w-emulsion (also referred to as oil-in- water emulsion), a water-immiscible organic liquid phase which does not have to be an "oil" by any specific definition (e.g. a liquid semifluorinated alkane phase i.e. a liquid phase comprising, or essentially consisting of one or more semifluorinated alkanes, and optional excipient, such as surfactant), is dispersed in a water-miscible continuous phase which may or may not be substantially comprised of water itself. In some embodiments, where the pharmaceutical composition is in the form of an emulsion, the emulsion is an o / w emulsion, e.g. wherein the dispersed phase comprises or essentially consists of one or more semifluorinated alkanes and optional one or more excipients, and an aqueous phase substantially comprising of water (with optional excipient(s)) is the continuous phase. Alternatively, the emulsion may be a w / o emulsion i.e. a water-in-oil emulsion, e.g. wherein the continuous phase comprises or essentially consists of one or more semifluorinated alkanes and optionally one or more other excipients, and the aqueous phase, e.g. comprising lifitegrast (and optional excipient(s)) dissolved in said phase, is the dispersed phase of the emulsion. In some embodiments, lifitegrast is dissolved in the aqueous phase of the vehicle. In some embodiments of the pharmaceutical composition, e.g. where the composition is in the form of an emulsion, the vehicle comprises between 30 to 70 vol %, or between 40 to 60 vol % of the semifluorinated alkane or the semifluorinated alkane phase. As understood in this context the vol % refers to percentage in respect of the total volume of the vehicle. Alternatively, the vehicle may comprise of between 30 to 70 wt %, or between 40 to 60 wt % of the semifluorinated alkane, or semifluorinated alkane phase, with respect to the total weight of the vehicle. In some embodiments of the pharmaceutical composition as described herein, e.g. where the composition is in the form of an emulsion, the vehicle comprises between 30 to 70 vol %, or 40 to 60 vol % of the aqueous phase with respect to the total volume of the vehicle. Alternatively, the vehicle may comprise of between 30 to 70 w t%, or 40 to 60 wt % of the aqueous phase, with respect to the total weight of the vehicle. The pharmaceutical composition, in the form an emulsion and comprising an aqueous phase may comprise lifitegrast (e.g. dissolved in said phase) and / or one or more components selected from any one of the following or combinations of the following: (i) a surfactant; (ii)a buffer salt; (iii) a preservative. The one or more components may also be dissolved or solubilized in the aqueous phase. The surfactant is preferably a polyethoxylated sorbitan fatty acid ester such as polysorbate 20, polysorbate 60, and polysorbate 80 (i.e. Tween^20 / 60 / 80). The buffer salt may be selected from phosphate, citrate, borate, Tris-HCl (Tris). In some preferred embodiments, the buffer salt is a phosphate salt (e.g. selected from sodium phosphate dibasic pentahydrate, sodium phosphate monobasic monohydrate, and sodium phosphate dibasic anhydrous). The preservative may be selected from benzalkonium chloride or other quaternary ammonium compounds such as polyquaternium-1 (polyquad), sodium perborate, and a preservative system e.g. oxochloro complexes such as Purite®; or sofZia®. In a preferred embodiment, the preservative is benzalkonium chloride. In some embodiments, the surfactant is featured in the vehicle in an amount of 3 to 5 wt % with respect to the total weight of the semifluorinated alkane(s) in the vehicle. In some embodiments, the vehicle comprises (i) between 3 to 5 wt % of polysorbate 80 (e.g. Tween® 80), or (ii) between 3 to 4 wt % polysorbate 20 (e.g. Tween® 20), with respect to the total weight of the semifluorinated alkane(s) in the vehicle. In some embodiments, the compositions according to the present disclosure may comprise of a vehicle comprising, in addition to the at least one semifluorinated alkane, one or more excipients. In one embodiment, the vehicle of the composition consists of at least one semifluorinated alkane and one or more excipients. The term “excipients” as used herein refers to any pharmaceutically acceptable, natural, synthetic or semi-synthetic substance, compound or component that may be included in the vehicle and thus the composition as described herein, for example to enhance or otherwise modify the physical or chemical constitution or stability of the composition. Pharmaceutically acceptable means that the excipient is safe, non-toxic, biocompatible and physiologically tolerated e.g. for human pharmaceutical use; preferably, the excipient is suitable and safe for topical administration to a human eye or its associated ophthalmic tissues. Examples of excipients which may be featured in the compositions according to the present disclosure include, but are not limited to, co-solvents, antioxidants, a preservative, lipids, oily excipients, surfactants, lubricant or combinations thereof. In one embodiment, the excipient is a liquid which is miscible with a semifluorinated alkane, and in case of more than one excipient being featured in the vehicle, also miscible with any of the other excipients featured in the vehicle of the composition. The excipient in one embodiment may function as a co- solvent, i.e. is a compound which is suitable for enhancing solubility or solubilizing the active compound e.g. lifitegrast, and / or another excipient featured in the composition. The co- solvent is preferably a liquid that is fully miscible with the semifluorinated alkane, i.e. it mixes with the semifluorinated alkane to form a coherent and single phase. In another embodiment, the excipient may be dissolved in the semifluorinated alkane. In some embodiments, the excipient is a co-solvent. The co-solvent may be an alcohol, such as an alkyl alcohol. In one embodiment, the alcohol is selected from ethanol, 1-propanol, isopropanol, and phenylethyl alcohol; or more preferably from ethanol and phenylethyl alcohol. Alternatively, the vehicle of the composition may comprise, or consist of, in addition to a semifluorinated alkane and optionally a structural isomer thereof, or mixture of two different semifluorinated alkanes such as defined herein, at least one excipient, with the proviso that the excipient is not an alcohol. In the embodiments of the disclosure where the composition is a suspension of lifitegrast, the excipient(s) are not co-solvents. In related embodiments, an excipient if present in the composition, is not a surfactant and / or is not an antioxidant. In some embodiments, the excipient featured in the vehicle is an oily excipient. Examples of oily excipients are triglycerides, mineral oil, and liquid paraffin. In one embodiment, in addition to a semifluorinated alkane the vehicle comprises an oily excipient is selected from medium chain triglycerides (MCT) and light liquid paraffin. In some embodiments, the excipient featured in the vehicle is an aqueous component, selected from water, an aqueous buffer (i.e. phosphate buffer), and a salt solution (i.e. saline). In the embodiments of the disclosure where the composition is an emulsion comprising lifitegrast and a semifluorinated alkane, one or more excipients are selected from an aqueous component (e.g. water, buffer-solution, salt-solution), a surfactant, a preservative, an antioxidant. In said embodiments, the aqueous component may be present in an amount such that it forms the bulk or continuous phase of the emulsion, or vice versa, depending on relative amount of the semifluorinated alkane, may form or be comprised in the dispersed phase of the emulsion. In some embodiments, the vehicle of the composition comprises, or consists of at least one semifluorinated alkane and a combination of any one of a co-solvent or oily excipient as described herein above. In some embodiments, the one or more excipients is present in the composition, optionally independently, in an amount of up to 0.1 wt %, 0.5 wt%, 0.75 wt%, 1.0 wt%, 1.25 wt%, 1.4 wt%, 1.5 wt%, 1.8 wt%, 2.0 wt%, 3.0 wt%, 4.0 wt% or up to 5.0 wt% (w / w), or preferably up to 1 wt% or up to 1.4 wt%, based on the total weight of the composition. In other embodiments, the composition comprises one or more excipients, optionally independently, in an amount of between 0.1 to 5.0 wt%, or between 0.1 to 2.0 wt% or between 0.01 to 1.4 wt%, based on the total weight of the composition. In other embodiments, the one or more excipients is present in the composition, optionally independently, in an amount of up to 0.1 % (v / v), 0.5 % (v / v), 0.75 % (v / v), 1.0 % (v / v), 1.25 % (v / v), 1.4 % (v / v), 1.5 % (v / v), 1.8 % (v / v), 2.0 % (v / v), 3.0 % (v / v), 4.0 % (v / v) or up to 5.0 % (v / v), or preferably up to 1 % (v / v) or up to 1.4 % (v / v), based on the total volume of the composition. In other embodiments, the composition comprises one or more excipients, optionally independently, in an amount of between 0.1 to 5.0 % (v / v), or between 0.1 to 2.0 % (v / v) or between 0.01 to 1.4 % (v / v), based on the total volume of the composition. In some embodiments, the composition is essentially free of a) water; or b) a preservative; or c) and antioxidant; d) a surfactant and / or e) any one or combination of a) b), c) and d). In a related embodiment, the composition is essentially free of one or more lifitegrast degradation products. In some embodiments, the composition is essentially free of an antioxidant, e.g. an antioxidant (or combinations of antioxidants) to prevent, or to reduce the rate of oxidative degradation of lifitegrast. Preferably, the composition is free of an antioxidant selected from the group consisting of propyl, octyl and dodecyl esters of gallic acid, butylated hydroxyanisole (BHA), green tea extract, uric acid, cysteine, pyruvate, nordihydroguaiaretic acid, ascorbic acid, salts of ascorbic acid such as ascorbyl palmitate and sodium ascorbate, ascorbyl glucosamine, vitamin E (i.e., tocopherols such as alpha-tocopherol), derivatives of vitamin E (e.g., tocopheryl acetate), retinoids such as retinoic acid, retinol, trans-retinol, cis- retinol, mixtures of trans-retinol and cis-retinol, 3-dehydroretinol and derivatives of vitamin A (e.g., retinyl acetate, retinal and retinyl palmitate, sodium citrate, sodium sulfite, lycopene, anthocyanids, bioflavinoids (e.g., hesperitin, naringen, rutin and quercetin), superoxide dismutase, glutathione peroxidase, butylated hydroxytoluene (BHT), indole-3-carbinol, pycnogenol, melatonin, sulforaphane, pregnenolone, lipoic acid and 4-hydroxy-5-methyl- 3[2H]-furanone, acetylcysteine, thioglycerol, Vitamin E TPGS, a thiosulfate salt (e.g. sodium thiosulfate), a metabisulfite salt (e.g. sodium metabisulfite) and a bisulfite salt (e.g. sodium bisulfite). More preferably, the composition of the present disclosure is free of a thiosulfate salt, such a sodium thiosulfate. In some embodiments, the composition of the present disclosure consists of lifitegrast dissolved or suspended in a vehicle comprising or consisting of a semifluorinated alkane and optionally one or more excipients, wherein the composition is essentially free of an antioxidant. In some embodiments, the composition consists of lifitegrast dissolved or suspended in a vehicle comprising or consisting of one or more semifluorinated alkanes and optionally one or more excipients, provided that the composition is essentially free of an antioxidant, preferably wherein the antioxidant is selected from the group consisting of propyl, octyl and dodecyl esters of gallic acid, butylated hydroxyanisole (BHA), green tea extract, uric acid, cysteine, pyruvate, nordihydroguaiaretic acid, ascorbic acid, salts of ascorbic acid such as ascorbyl palmitate and sodium ascorbate, ascorbyl glucosamine, vitamin E (i.e., tocopherols such as alpha-tocopherol), derivatives of vitamin E (e.g., tocopheryl acetate), retinoids such as retinoic acid, retinol, trans-retinol, cis-retinol, mixtures of trans-retinol and cis-retinol, 3- dehydroretinol and derivatives of vitamin A (e.g., retinyl acetate, retinal and retinyl palmitate, sodium citrate, sodium sulfite, lycopene, anthocyanids, bioflavinoids (e.g., hesperitin, naringen, rutin and quercetin), superoxide dismutase, glutathione peroxidase, butylated hydroxytoluene (BHT), indole-3-carbinol, pycnogenol, melatonin, sulforaphane, pregnenolone, lipoic acid and 4-hydroxy-5-methyl-3[2H]-furanone, acetylcysteine, thioglycerol, Vitamin E TPGS, a thiosulfate salt (e.g. sodium thiosulfate), a metabisulfite salt (e.g. sodium metabisulfite) and a bisulfite salt (e.g. sodium bisulfite). Preferably, the composition consists of lifitegrast dissolved or suspended in a vehicle comprising or consisting of one or more semifluorinated alkanes and optionally one or more excipients, wherein the one or more semifluorinated alkanes are selected from 1- perfluorbutylpentane (F4H5), 2-perfluorobutylpentane, 1-perfluorohexyloctane (F6H8) and 2-perfluorohexyloctane, provided that the composition is essentially free of a thiosulfate salt (e.g. sodium thiosulfate). In a preferred embodiment, the composition consists of 5 % (w / v) lifitegrast dissolved or suspended in a vehicle comprising or consisting of one or more semifluorinated alkanes and optionally one or more excipients, wherein the one or more semifluorinated alkanes are selected from (i) a mixture of 1-perfluorobutyl-pentane and 2-perfluorobutyl-pentane, and (ii) a mixture of 1-perfluorohexyloctane and 2-perfluorohexyloctane; and provided that the composition is essentially free of a thiosulfate salt (e.g. sodium thiosulfate). In a further embodiment, the composition consists of 5% (w / v) lifitegrast dissolved or suspended in a vehicle comprising or consisting of one or more semifluorinated alkanes and optionally one or more excipients, wherein the one or more semifluorinated alkanes are selected from (i) a mixture of at least 97 wt % 1-perfluorobutyl-pentane and 3 wt % or less of 2-perfluorobutyl-pentane, and (ii) a mixture of at least 97 wt % 1-perfluorohexyl-octane and 3 wt % or less of 2-perfluorohexyloctane, based on the total weight of the vehicle; and provided that the composition is essentially free of a thiosulfate salt (e.g. sodium thiosulfate). Surprisingly, it was found that the oxidative degradation (and associated loss) of lifitegrast is reduced or essentially avoided in the composition of the present disclosure, despite the high content of up to about 8 vol % oxygen saturation in the vehicle or in the composition (translating to a concentration of about 10 mg / ml oxygen) comprising or consisting of one or more semifluorinated alkanes, and optionally one or more excipients. Sparging the vehicle with an inert gas, such as nitrogen, in order to replace the high content of oxygen, preferably before lifitegrast is added, is not necessary to reduce or essentially avoid oxidative degradation of lifitegrast in the composition. And further, the addition of an antioxidant is also not necessary to prevent oxidative degradation of lifitegrast. In some embodiments according to the present disclosure, the oxygen content in the pharmaceutical composition comprising lifitegrast is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol% in respect of the total volume of the composition. In some embodiments, the composition comprises or consists of lifitegrast suspended in a vehicle consisting of one or more semifluorinated alkanes selected from 1-perfluorobutyl- pentane (F4H5), 2-perfluorobutyl-pentane, 1-perfluorohexyl-octane (F6H8) and 2- perfluorohexyl-octane, wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5 vol %, 6 vol %, 7 vol % or up to about 8 vol % with respect to the volume of the composition. More preferably, the composition of the present disclosure comprises or consists of lifitegrast suspended in vehicle consisting of (i) a mixture 1-perfluorobutyl- pentane and 2-perfluorobutyl-pentane, or of (ii) a mixture of 1-perfluorohexyl-octane and 2- perfluorohexyl-octane, wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5vol %, 6 vol %, 7 vol % or up to about 8 vol %. Even more preferable, the composition of the present disclosure comprises or consists of solid particles of lifitegrast suspended in vehicle consisting of: (i) at least 97 wt % of 1-perfluorobutylpentane and 3 wt % or less of 2-perfluorobutyl-pentane, or of (ii) at least 97 wt % of 1-perfluorohexyl-octane and 3 wt % or less of 2-perfluorohexyl-octane, based on the weight of the vehicle, and wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5 vol %, 6 vol %, 7 vol % or up to about 8 vol % with respect to the volume of the composition. In some embodiments, the composition comprises or consists of lifitegrast suspended in vehicle consisting of one or more semifluorinated alkanes selected from 1-perfluorobutyl- pentane (F4H5), 2-perfluorobutyl-pentane, 1-perfluorohexyloctane (F6H8) and 2- perfluorohexyl-octane, wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5 vol %, 6 vol %, 7 vol %, 8 vol %, 9 vol % or up to about 10 vol %, or wherein the oxygen content in the composition is between 4 to 5 vol %, wherein the composition is essentially free of an antioxidant. More preferably, the composition of the present disclosure consists of lifitegrast suspended in vehicle consisting of (i) a mixture 1-perfluorobutyl- pentane and 2-perfluorobutyl-pentane, or of (ii) a mixture of 1-perfluorohexyl-octane and 2- perfluorohexyl-octane, wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5 vol %, 6 vol %, 7 vol %, 8 vol %, 9 vol % or up to about 10 vol %, or wherein the oxygen content in the composition is between 4 to 5 vol %, wherein the composition is essentially free of an antioxidant. Even more preferable, the composition of the present disclosure may consist of solid particles of lifitegrast suspended in vehicle consisting of (i) at least 97 wt% of 1-perfluorobutyl-pentane and 3 wt % or less of 2-perfluorobutyl-pentane, or of (ii) at least 97 wt % of 1-perfluorohexyl-octane and 3 wt% or less than 3 wt% of 2- perfluorohexyl-octane, based on the weight of the vehicle, and wherein the oxygen content in the composition is of up to about 3 vol %, 4 vol %, 5 vol %, 6 vol %, 7 vol %, 8 vol %, 9 vol % or up to about 10 vol %, or wherein the oxygen content in the composition is between 4 to 5 vol % with respect to the volume of the composition, provided that the composition is essentially free of an antioxidant. Oxygen content may be determined using methods in the art, for example with a chemical optical oxygen microsensor, e.g. with measurement range of 0-250% air saturation. As used herein, the term “up to about” or “up to” used in context of a parameter, such as in relation to the concentration or amount of lifitegrast or an in relation to the amount of the one or more excipient in the composition, refers to any value of the parameter greater than zero and up to, and inclusive of, the defined parameter, taking into account any degree of variability usually observed in measuring or determining this parameter, using the standard techniques and equipment known in the relevant field. As understood herein, the term “% (w / v)” unless otherwise indicated refers to the amount of a component of a composition as a weight percentage in relation to the total volume of the composition (with “w” denoting weight and “v” denoting volume). For example, a 0.1 % (w / v) would correspond to 1.0 mg of a component in 1 mL of the composition. The term “% (w / w)” or alternatively, “wt %” as used herein and unless otherwise indicated refers to the amount of a component in a composition as a weight percentage in relation to the total weight of the composition with ‘w’ denoting weight. The term % (v / v) or vol %, or volume percent as used herein, and unless otherwise indicated, refers to the volume of a component of a composition in relation to the total volume of the composition. As understood herein, the term ‘essentially free’, or alternatively ‘substantially free’ or ‘component-free’ in reference to a composition constituent or component refers to the presence of said component in no more than trace amounts and that if present in trace amounts the component does not provide any technical contribution or material advantage to the composition. The compositions described herein are, in one embodiment, essentially free of water. In another embodiment, the composition as described herein may be essentially free of a preservative, such as an anti-microbial preservative, or an antioxidant. In other embodiments, the composition as descried herein essentially free of a surfactant. The term ‘about’ as used herein and in reference or connection to a parameter, for example such as the amount or concentration of a compound dissolved or suspended in the composition includes the precise value as defined, as well as any value falling within the degree of variability usually observed in measuring or determining these parameters using the standard techniques and equipment known in the art and field. Also as understood herein, a pharmaceutically acceptable salt is a salt of a compound such as provided herein, which retains its biological properties, and which is non-toxic and is compatible for pharmaceutical use. Salts, for example, may result from an addition of an acid, such as an organic acid or a mineral acid, such as sulfuric acid, or hydrochloric acid. Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist, having a chemical formula as follows: Chemical names for lifitegrast include (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4- tetrahydroisoquinoline-6carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid, or (2S)- 2-{[2-(1-benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6- yl]formamido}-3-(3-methanesulfonylphenyl)propanoic acid. As discussed herein above, the disclosure relates to a pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, wherein the lifitegrast is dissolved or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients such as defined above. A composition containing higher enantiomeric ratio, or predominantly lifitegrast may be formulated in a semifluorinated alkane and remain stable also under long term storage conditions, in particular long-term storage conditions. Stability may include reduction or even essentially complete avoidance of any degradation (and loss) of lifitegrast, for example, as may be the case for aqueous formulations which may require a complex buffering system and / or single-use packaging to control or mitigate exposure of the compound to environmental factors and changes and / or the presence of an antioxidant to control oxidation of the compound. Additionally, improvements in stability may also be in respect of a reduction in racemization potential and / or a reduction in changes of enantiomeric ratio in respect to the formation of the enantiomer, or (R)-isomer of lifitegrast over time and during storage. Overall, the present disclosure may provide improvements with respect to shelf-stability of lifitegrast, and maintaining a longer-term integrity of the concentration of said active ingredient with respect to its availability for its intended therapeutic use. Shelf-stable concentration compositions of lifitegrast may thus be formulated in the semifluorinated alkanes according to the present disclosure, also avoiding the disadvantage of presence or formation of substantial amounts of its enantiomer (lifitegrast (R)-isomer) which may be considered as an impurity. Although the lifitegrast (R)- isomer has a low or no pharmacological effect in respect of intended therapeutic use in particular for the treatment of dry eye disease, the absence, or else a much lower amount of this enantiomer in the composition may be advantageous in that this reduces or avoids unnecessary exposure of a subject in need of the treatment to a compound that a subject’s physiology may still be reactive to. In one embodiment, the composition according to the disclosure comprises an enantiomeric mixture of lifitegrast and its enantiomer i.e. its (R)-enantiomer, which may also be defined as (R)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6 carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid, or (2R)-2-{[2-(1-benzofuran-6- carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6-yl]formamido}-3-(3- methanesulfonylphenyl)propanoic acid. The molecular structure of this isomer is: This isomer may also be referenced as ‘Impurity 8’ and as used herein the term ‘lifitegrast (R)-isomer’ may be understood as referring to this enantiomer of lifitegrast. In one embodiment, the enantiomeric ratio of lifitegrast to its enantiomer (lifitegrast (R)- isomer) is not 50:50. Or in other words, the composition does not comprise, is not, or will not become a racemic mixture of the two enantiomers. In one embodiment, the composition comprises at least 80% lifitegrast, at least 89% lifitegrast, at least 90% lifitegrast, at least 93 % lifitegrast or at least 95 % lifitegrast, or at least 96% lifitegrast, or at least 97% lifitegrast, or at least 98% lifitegrast, or at least 99% or at least 99.5% lifitegrast based on the total amount of the compound and its enantiomer in the composition. In one embodiment, the composition comprises lifitegrast in at least about 78%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 93%, 96%, 97%, 98%, 99% or 99.5 % enantiomeric excess. The enantiomeric excess (ee) is a measurement of purity used for chiral substances. It reflects the degree to which a sample contains one enantiomer (i.e. lifitegrast) in greater amounts than its (R)-enantiomer, i.e. a greater proportion in amount of (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6 carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid as compared to (R)-2-(2- (benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6 carboxamido)-3-(3- (methylsulfonyl)phenyl)propanoic acid. A racemic mixture has an ee of 0%, while a single completely pure enantiomer has an ee of 100%. A sample with 70% of lifitegrast and 30% of lifitegrast (R)-isomer has an ee of 40% (70% − 30%). In some embodiments, the enantiomeric excess of lifitegrast to its enantiomer (lifitegrast (R)- isomer) in the composition after storage at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, 12 months is at least 90%, or at least 95% or at least 99% relative to the initial enantiomeric excess of lifitegrast in the composition. In some embodiments, the composition according to the present disclosure comprises less than 10% of the lifitegrast enantiomer (lifitegrast (R)-isomer) or less than 5% of the lifitegrast enantiomer (lifitegrast (R)-isomer), or less than 2% of the lifitegrast enantiomer (lifitegrast (R)-isomer) or less than 1% of the lifitegrast enantiomer (lifitegrast (R)-isomer) or less than 0.5% of the lifitegrast enantiomer (lifitegrast (R)-isomer) based on the total amount of lifitegrast and its enantiomer (lifitegrast (R)-isomer) in the composition. In some embodiments, the enantiomeric ratio of lifitegrast to its enantiomer (lifitegrast (R)- isomer) in the composition is at least 89:11, 90:10, 91:8, 91:9, 92:8, 93:7, 94:6, 95:5, 96:4, 97:3, 98:2, 99:1, 99.5:0.5, 99.7:0.3 or at least 99.9:0.1. Enantiomeric ratio is the ratio of the percentage of one enantiomer to that of the other, and may alternatively also be expressed numerically. For example, for a racemate the enantiomeric ratio is 1 (50:50), or for an enantiomeric ratio of 90:10, this may be expressed as 9. In one embodiment, the enantiomeric ratio of lifitegrast to its isomer in the composition is at least 8, 9, 10, 11, 12, 13, 15, 32, 50, 100 or at least 250. The enantiomeric ratio, or the enantiomeric excess (ee) of lifitegrast, or in general, stereochemical purity thereof, and the quantification of the amount, relative or otherwise, of the lifitegrast, its enantiomer or degradation products associated with lifitegrast featured in a composition according to the present disclosure may be determined via a number of methods in the art, for example, but not limited to chromatography methods such as HPLC, capillary electrophoresis, LC-MS or gas chromatography, and / or spectroscopic methods such as circular dichroism or NMR. In one embodiment, the enantiomeric ratio is determined by HPLC, preferably from quantification of the peak areas of the respective compounds. In addition to the low amount or concentration of lifitegrast (R)-isomer in the composition, the pharmaceutical composition comprising lifitegrast, may also comprise only low amounts of, or may be essentially free of any degradation products. Degradation products of lifitegrast may include any products which are formed when lifitegrast, e.g. formulated in a liquid composition, is exposed to any one or combination of thermal, oxidative, photolytic, basic or acidic conditions. Lifitegrast degradation products include, but are not limited to, lifitegrast (R)-isomer or any degradation products formed upon exposure to thermal, oxidative, photolytic, basic or acidic stress conditions, such as featured in Examples 5, 6; for example the degradation products listed in Table 1, or featured in the chromatograms of Figure 1 or Figure 2. Alternatively, or additionally, the compositions of the present disclosure may comprise of no more than about 0.0001 to 0.001 %(w / v), or 0.004 to 0.006% (w / v) % lifitegrast (R)-isomer. The composition may also be substantially free of lifitegrast (R)-isomer. In some embodiments, the composition according to the present disclosure comprises lifitegrast, wherein the lifitegrast is present in the composition at a concentration of between 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v). In some embodiments, lifitegrast is in the composition at a concentration of up to 8 % (w / v), or up to 7 % (w / v), or up to 6 % (w / v) or up to 5 %(w / v). Further embodiments of the composition according to the present disclosure may include, but not be limited to a suspension of lifitegrast suspended in a semifluorinated alkane or mixture of semifluorinated alkanes as defined herein, wherein the composition comprises or consists of: a) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane; b) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof; c) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane, wherein the semifluorinated alkane is 1- perfluorobutyl-pentane optionally in combination with 2-perfluorobutyl-pentane, wherein the 2-perfluorobutyl-pentane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w), or up to 0.2% (w / w) in respect of the total weight of the combination of the semifluorinated alkanes; or d) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane, wherein the semifluorinated alkane is 1- perfluorohexyl-octane, optionally in combination with 2-perfluorohexyl-octane, wherein the 2-perfluorohexyl-octane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w) or up to about 0.2% (w / w)in respect of the total weight of the combination of the semifluorinated alkanes. In some embodiments, the liquid composition according to the present disclosure, comprises or consists of: a) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast, 1- perfluorobutyl-pentane, and optionally one or more excipients; b) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast, 1- perfluorobutyl-pentane, and optionally one or more excipients, optionally in combination with 2-perfluorobutyl-pentane, wherein the 2-perfluorobutyl-pentane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w), or up to 0.2% (w / w) in respect of the total weight of the combination of the semifluorinated alkanes, c) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1-perfluorobutyl-pentane, and optionally one or more excipients, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2. d) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1-perfluorobutyl-pentane, and optionally one or more excipients, wherein: - the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2 and - after storage at 1, 2, or 3 months at 25°C, the total amount of lifitegrast and lifitegrast (R)- isomer is at least 99.9%, 99.5%, 99%, 98%, 97%, 96 % or at least 95% relative to the initial amount thereof in the composition; and -optionally, enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer has not decreased by more than 0.25%, 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25%; e) about 5 %(w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorobutyl-pentane and optionally one or more excipients, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2 or at least 99:1; or at least 99.8:0.2; f) about 5 % (w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorobutyl-pentane, and optionally one or more excipients, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2 or at least 99:1; or at least 99.8:0.2 and wherein after storage at 1, 2, or 3 months at 25°C, the total amount of lifitegrast in the composition is at least 99.9%, 99.5%, 99%, 98%, 97%, 96 % or at least 95% relative to the initial amount of lifitegrast in the composition and optionally, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer has not decreased by more than 0.25%, 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25%. g) about 5 % (w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorobutyl-pentane and optionally up to 1 wt% of one or more excipients, e.g. ethanol, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2 or at least 99:1; or at least 99.8:0.2. The compositions a), b) c), d), e), f), and g) are in some embodiments, suspensions wherein lifitegrast (and its (R)-isomer) are particles suspended in a liquid vehicle which comprises or consists of 1-perfluorobutyl-pentane and the optional excipient. In a related embodiment, the semifluorinated alkane featured in these compositions may be a mixture according to the present disclosure of 1-perfluorobutyl-pentane and a structural isomer thereof, such as 2- perfluorobutyl-pentane. According to further embodiments, the present disclosure also relates to liquid compositions consisting or comprising: j) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast, 1- perfluorhexyl-octane, and optionally one or more excipients k) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast, 1- perfluorohexyl-octane and optionally one or more excipients, optionally in combination with 2-perfluorohexyl-octane, wherein the 2-perfluorohexyl-octane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w), or up to 0.2% (w / w) in respect of the total weight of the combination of the semifluorinated alkanes, l) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1-perfluorohexyl-octane and optionally one or more excipients, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer present in the composition is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2 or m) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1-perfluorohexyl-octane, and optionally one or more excipients, wherein: -the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2; and -after storage at 1, 2, or 3 months at 25°C, the total amount of lifitegrast is at least 99.9%, 99.5%, 99%, 98%, 97%, 96 % or at least 95% relative to the initial amount of lifitegrast in the composition; and -optionally, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer has not decreased by more than 0.25%, 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25%; n) about 5% (w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorohexyl-octane and optionally one or more excipients, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2. o) about 5% (w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorohexyl-octane, and optionally one or more excipients, wherein - the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2 ; or at least 99:1; or at least 99.8:0.2 and -after storage at 1, 2, or 3 months at 25°C, the total amount of lifitegrast in the composition is at least 99.9%, 99.5%, 99%, 98%, 97%, 96 % or at least 95% relative to the initial amount of lifitegrast in the composition and - optionally, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer has not decreased by more than 0.25%, 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25%. p) about 5% (w / v) of an enantiomeric mixture of lifitegrast and lifitegrast (R)-isomer, 1- perfluorohexyl-octane and optionally up to 1 wt% of one or more excipients, e.g. ethanol, wherein the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is at least 90:10, at least 95:5, at least 96:4; or at least 98:2; or at least 99:1; or at least 99.8:0.2. The compositions j), k), l), m), n), o) and p), are in some embodiments, suspensions, wherein lifitegrast (and its isomer) are suspended as particles in a liquid vehicle which comprises or consists of 1-perfluorohexyloctane and the optional excipient. In a related embodiment, the semifluorinated alkane featured in these compositions may be a mixture of 1-perfluorohexyl- octane and a structural isomer thereof, such as 2-perfluorohexyl-octane. In some embodiments, the composition consists of lifitegrast suspended in vehicle consisting of one or more semifluorinated alkanes selected from 1-perfluorobutyl-pentane (F4H5), 2- perfluorobutyl-pentane, 1-perfluorohexyl-octane (F6H8) and 2-perfluorohexyl-octane. In other embodiments, the composition of the present disclosure consists of lifitegrast suspended in vehicle consisting of: (i) a mixture 1-perfluorobutyl-pentane and 2- perfluorobutyl-pentane, or (ii) a mixture of 1-perfluorohexyl-octane and 2-perfluorohexyl- octane. In a preferred embodiment, the composition of the present disclosure consists of solid particles of lifitegrast suspended in vehicle consisting of: (i) at least 97 wt % of 1- perfluorobutyl-pentane and 3 wt % or less of 2-perfluorobutylpentane, or (ii) at least 97 wt % of 1-perfluorohexyl-octane and 3 wt % or less of 2-perfluorohexyl-octane, based on the weight of the vehicle. In some embodiments, the amount of lifitegrast in a composition according to the present disclosure, after storage at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months is at least 90%, or at least 95% or at least 99% relative to the initial amount of lifitegrast determined for the composition, e.g. by HPLC. In other embodiments, the concentration or amount of lifitegrast in a composition according to the present disclosure, after storage at 0 to 60°C, e.g. storage at 25°C for at least 1, 2, 3, 4, 5, 6, 9 or at least 12 months is in the range of 90 to 110%, or 95 to 105 % of the initial concentration of lifitegrast in the composition e.g. as determined by HPLC. In other embodiments, the concentration of lifitegrast after storage of the composition at 25°C for at least 3 months is in the range of about 90-110%; or is not less than 90% (e.g.91, 92 ,93 ,94, 95 ,96, 97, 98, 99%); or is not higher than 100% (e.g. not higher than 101, 102, 103, 104, 105, 106, 107, 108, or 109%), e.g. as determined by HPLC, preferably by quantification of the peak areas of the respective compounds. Where the percentage determined is greater than 100%, it is to be understood that the measurement does not relate to an increase in amount of lifitegrast, but e.g. rather translates to a loss of vehicle over time during storage. In further related embodiments, the amount of lifitegrast or preferably equal or greater than 90%, or 95% of the initial concentration of lifitegrast in the composition, or equal to or less than 110%, 105 % or 100% of the initial concentration of lifitegrast in the composition. In some embodiments, the enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer in a composition according to the present disclosure after storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or at least 12 months has not decreased by more than 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25%. For example, in a composition comprising lifitegrast and its (R)- isomer, suspended and dissolved in an semifluorinated alkane and optional excipient(s), if the initial enantiomeric ratio of lifitegrast to lifitegrast (R)-isomer is 90:10, i.e.9, prior to storage or aging, a decrease of about 1% would amount to a decrease of the enantiomeric ratio to 8.91%, or about 89.91 : 10.09. In some embodiments, the amount of lifitegrast after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months in the composition is at least 90%, or at least 95% or at least 97%, or at least 98% or at least 99% relative to the initial amount of lifitegrast in the composition, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol% in respect of the total volume of the composition. In another aspect, the disclosure relates to a method for the preparation of a composition as defined according to any one of the embodiments described herein; said method comprising a step of dissolving or suspending lifitegrast in a non-aqueous vehicle comprising, or consisting of a semifluorinated alkane, and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers and any combination thereof. In other embodiments, the disclosure relates to a method for the preparation of a composition, wherein the composition is in the form of an emulsion, wherein the method comprises a step of dissolving lifitegrast in an aqueous phase, the aqueous phase optionally comprising one or more excipients and combining said aqueous phase with a liquid phase comprising, or consisting of a semifluorinated alkane, and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers and any combination thereof. In some embodiments of these methods, after storage of the composition for a period of at least 1, 2, 3, 4, 5, 6, 9 or 12 months at 0 to 60 °C (e.g. at 25 °C), the amount of the (R)-isomer of lifitegrast in the composition is independently less than 10%, less than 5%, less than 4% , less than 3%, less than 2%, less than 1% or less than 0.5% (e.g. by HPLC). In a related aspect, the disclosure relates to a method for stabilizing lifitegrast in a composition, the method comprising a step of dissolving or suspending lifitegrast (of certain optical purity) in a semifluorinated alkane, or a non-aqueous vehicle comprising a semifluorinated alkane, and optionally one or more excipients; wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, their structural isomers, and any combination thereof. In some embodiments according to this method, the lifitegrast has an enantiomeric excess of at least 80 % ee, at least 80% ee, at least 90 %, 95 %, 97% ee or at least 99% ee, or a purity of at least 90% or at least 95% or at least 97% or at least 98% or at least 99 % (e.g. by HPLC). In other embodiments, the enantiomeric purity or ratio of the lifitegrast may be as defined above. In yet another related aspect, the disclosure provides for a method for stabilizing lifitegrast in a composition, the method comprising a step of dissolving or suspending lifitegrast in a semifluorinated alkane as defined in any of the embodiments described herein. Further provided is a method for stabilizing lifitegrast in a composition, wherein the method comprises a step of dissolving or suspending lifitegrast in a vehicle comprising a semifluorinated alkane, and optionally one or more excipients as defined in any one of the embodiments described herein. These methods provide for example, a) a prevention of, or a reduction in the rate of degradation (e.g. hydrolysis and / or dehydration and / or oxidation) of lifitegrast in the composition; and / or b) a prevention of, or reduction in the rate of isomerization (e.g. racemization) of lifitegrast in the composition; and / or c) a prevention of, or reduction in the enantiomeric excess of the lifitegrast in the composition; and / or d) a prevention of, or reduction in the rate of formation of the lifitegrast enantiomer (lifitegrast (R)-isomer) in the composition; and / or e) a prevention or reduction in the rate of formation of lifitegrast degradation products, preferably a prevention or reduction in the rate of formation of lifitegrast degradation products formed from exposure to any one or combination of thermal, oxidative, photolytic, basic or acidic conditions. In particular, the method may be effective in any one or combination of: preventing or reducing the degradation of lifitegrast, in the composition; or preventing or reducing the conversion of lifitegrast to lifitegrast (R)-isomer in the composition, after a period of storage of the composition for at least 1, 2, 3, 4, 5, 6, 9 or 12 months at 0 to 60 °C, e.g.25 °C. In some embodiments of these methods, after a period of at least 1, 2, 3, 4, 5, 6, 9 or 12 months at 0 to 60 °C (e.g.25 °C), the amount of any one or more of a degradation product (for example, an oxidation degradation product) of lifitegrast is independently, less than 5%, less than 4%, less than 3%, less than 2%, less than 1%, or less than 0.5% (e.g. by HPLC). In some embodiments, of these methods, after a period of at least 1, 2, 3, 4, 5, 6, 9, or 12 months at 0 to 60 °C (e.g.25 °C), the amount of lifitegrast (R)-isomer in the composition is less than 10%, less than 5%, less than 4% , less than 3%, less than 2%, less than 1% or less than 0.5% (e.g. by HPLC). In other embodiments, after storage at 0 to 60 °C (e.g. at 25 °C) for a period of at least 1, 2, 3, 4, 5, 6, 9, or 12 months, the enantiomeric ratio of lifitegrast to lifitegrast (R)- isomer in the composition decreases by less than 0.5%, 1.0%, 2.0%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, or 25% (e.g. as determined by HPLC). In some embodiments, the method comprises a step of suspending lifitegrast in a vehicle comprising or consisting of at least 90, 93, 95, 96, 97 ,98, 99 or at least 99.5 wt% of F6H8 (1- perfluorohexyl-octane), and optionally up to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2 or up to 3 wt% of 2-perfluorohexyl-octane. The method may be effective in reducing the amount of lifitegrast degradation product(s) to less than 10%, 8%, 6 %, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25% or less than 0.1% relative to the initial mount of lifitegrast in the composition. In some embodiments, the method is effective in retaining the amount of lifitegrast in the composition, after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months, in an amount of at least 90%, or at least 95%, or at least 97%, or at least 98%, or at least 99% relative to the initial amount of lifitegrast in the composition. In some embodiments, the composition comprises less than 10%, 8%, 6 %, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25% or less than 0.1% of lifitegrast degradation products, relative to the initial mount of lifitegrast in the composition. Said degradation products of lifitegrast may be formed from exposure of the composition to one or more of thermal, oxidative, photolytic, basic or acidic conditions. In some embodiments, the degradation products of lifitegrast are formed from exposure to thermal, oxidative or photolytic conditions. In further embodiments, said degradation products of lifitegrast are formed from exposure to oxidative conditions. In a yet a further aspect, the pharmaceutical compositions according to the present disclosure are useful or are provided as a medicine, for use in the treatment or prevention of disease or medical conditions, preferably of a human subject, or optionally, mammalian or veterinary subjects; and in the manufacture of a medicament. In some embodiments, the composition is a topical ophthalmic composition, or in other words, a composition which is adapted and formulated for topical administration to the eye, in particular to for administration to the surface of a subject’s eye, or tissues associated with the eye, such as to the cornea and / or conjunctiva of the eye, or to the cul-de-sac of the conjunctiva. In one related embodiment, said composition is in the form of a clear solution. In another related embodiment, said composition is a topically administrable ophthalmic suspension; a suspension of solid particles comprising, or consisting of lifitegrast suspended (or suspendable) in a liquid vehicle and / or liquid semifluorinated alkane such as described herein. In one aspect, the composition according to any one or combination of embodiments according to the present disclosure is used for the treatment, and / or prevention of an ophthalmic disease or condition, e.g. affecting one or both eyes of a subject. In a further aspect, the composition according to the embodiments in the present disclosure comprising lifitegrast or a pharmaceutically acceptable salt thereof is used for the treatment, prevention and / or for the reduction of dry eye disease; or for the treatment, prevention and / or reduction of signs or symptoms of dry eye disease; or for the treatment, prevention or reduction of an ocular surface disease, preferably an ocular surface disease affecting the cornea and / or the conjunctiva, or an ocular surface disease associated with inflammation of the cornea and / or conjunctiva; or for increasing tear production in at least one, or both eyes of a subject a suffering from dry eye disease; or for the treatment of an autoimmune disorder of the ocular surface. In some embodiments, the composition according to the present disclosure is used for the treatment of signs and symptoms of dry eye disease. Dry eye disease (also abbreviated as DED, and also synonymous or known as keratoconjunctivitis sicca, dysfunctional tear syndrome or dry eye syndrome) is a complex disease that results in symptoms of discomfort, visual disturbance, and tear film instability, and which creates potential for damage of the ocular surface. It may be accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. A patient having dry eye disease may experience any one, or a combination of tear hyperosmolarity, tear film instability or abnormalities in the lipid layer composition of the tear film. Two major categories of dry eye disease (DED) or keratoconjunctivitis sicca may be distinguished: aqueous-deficient dry eye disease and evaporative dry eye disease. Further sub-types may be classified within these two categories. Subjects suffering from aqueous- deficient dry eye typically are characterized by insufficient or low levels of tear production, for example due to a lacrimal gland insufficiency, lacrimal duct obstruction or a reflex hyposecretion. Evaporative dry eye disease is also somewhat heterogeneous and can develop as a result of diverse root causes. One of the major causes is meibomian gland disease or dysfunction, eyelid aperture disorders, blink disorders or other ocular surface disorders. Signs of dry eye disease may comprise damage of the corneal surface, damage of the conjunctival surface, inflammation of the corneal surface, inflammation of the conjunctival surface, decreased tear production and any combinations thereof. These signs may be determined by taking objective clinical measurements of a subject’s eye with respect to such signs using characterization methods and tests in the art that have been developed for quantifying such signs, for example, corneal fluorescein staining (e.g. for grading, and assessing corneal damage and / or inflammation), conjunctival staining (e.g. for grading and assessing conjunctival damage and / or inflammation), or a Schirmer’s Test I (e.g. for assessing level of tear production). The symptoms of dry eye disease may comprise dry, scratchy, gritty, or sandy feeling in the eye; foreign body sensation; pain or soreness; stinging or burning; itching; increased blinking; eye fatigue; photophobia; blurry vision; redness; mucus discharge; contact lens intolerance; excessive reflex tearing, or any combinations thereof. These may be assessed for example by patient questionnaires. As noted herein, the compositions herein are preferably used for the treatment of a mammalian, or more preferably, a human subject. Moreover, the use of a pharmaceutical composition as described in any one of the above embodiments in the manufacture or preparation of a medicament or a medicine for the treatment of a subject in need thereof in relation to any one of the disease or medical conditions described herein is also provided for in the context of the present disclosure. Further provided for within the context of the present disclosure, are also methods of treating subjects with, or suffering from any medical conditions or disorders described herein; or methods of preventing or ameliorating medical conditions or disorders in said subjects, wherein said methods may comprise a step of administering (e.g. topical, e.g. topical ophthalmic administration) a composition as described herein to said subject. In yet another aspect, the present disclosure relates to a kit comprising a composition according to any one or combination of embodiments described herein, a container adapted for holding the composition and optionally a means for dispensing the composition and / or instructions for use, wherein the instructions for use comprise any one of the uses or methods of treatment as described herein. In some embodiments of the kit, the kit comprises a means for dispensing the composition, which may be affixed, or reversibly affixable to the container. The means for dispensing the composition may be a dropper or similar, or is adapted for the instillation of single drops of about 9 to 12 µl volume, or of about 10 to 11 µl, or of about 9 µl, or of about 10 µl, or of about 11 µl of the composition to an eye of the subject. In some embodiments of the kit, the container is adapted to hold a single dose of the composition or multiple doses of the composition, preferably with no preservative being present in the composition to prevent or to reduce microbial growth. In another aspect, the disclosure relates to a reduction of the dose of a commercially available aqueous lifitegrast product (Xiidra®), which is administered at a single dose of lifitegrast of 2.5 mg per eye or respectively at a (total) daily dose of 5 mg per eye. Decreasing exposure of a subject with regards to dosage or amount of an active compound may be beneficial, for example, with respect to reducing overall risks of adverse effects. In some embodiments of this aspect of the disclosure, a composition comprising 5 % (w / v) lifitegrast dissolved or suspended in a vehicle comprising a semifluorinated alkane as disclosed herein is topically administered to the eye of a human subject suffering from dry eye disease at a single dose of about 0.40 to 0.60 mg, or of about 0.45 to 0.55 mg, or of about 0.50 mg lifitegrast per eye. Preferably, the composition comprising 5% (w / v) lifitegrast dissolved or suspended in a vehicle comprising a semifluorinated alkane is topically administered to an eye of human subject suffering from dry eye disease twice daily, providing a single dose of about 0.40 to 0.60 mg, or of about 0.45 to 0.55 mg, or of about 0.50 mg of lifitegrast per eye twice per day. In the context of use of a composition as described in any of the embodiments herein in the manufacture of a medicament for treating dry eye disease, in some embodiments, the medicament may comprise at least one or a plurality of unit doses of lifitegrast, wherein the unit dose is about 0.40 to 0.60 mg, or of about 0.45 to 0.55 mg, or of about 0.50 mg lifitegrast per eye. In further embodiments of this aspect of the disclosure, the composition comprising 5 % (w / v) lifitegrast dissolved or suspended in a vehicle comprising a semifluorinated alkane as disclosed herein is topically administered to an eye of a human subject suffering from dry eye disease at a, or providing a total daily dose amount of about 0.80 to 1.20 mg, or of about 0.90 to 1.10 mg, or about 1.0 mg of lifitegrast per eye. Preferably, said total daily dose per eye is provided by topical administration of the composition twice daily to the eye of the subject. In another embodiment of this aspect of the disclosure, the composition comprising 5 % (w / v) lifitegrast is topically administered to the eye of a human subject suffering from dry eye disease at a single dose of a drop of about 9 to 12 µl, or of about 10 to 11 µl or of about 10 µl volume per eye. Preferably, a composition comprising 5% (w / v) lifitegrast as described herein is topically administered two times per day to an eye of the human subject suffering from dry eye disease at a single dose of a drop of about 9 to 12 µl, or of about 10 to 11 µl or of about 10 µl volume per eye per eye. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 depicts HPLC-chromatograms of 5 %(w / v) lifitegrast compositions (A), (B), and (C) as described in Example 6, after oxidative stress. Major degradation product peaks are shown for (A) at relative retention time (RRT) 0.67; for (B) at RRT 0.42, RRT 0.60, RRT 0.73. For (C), no major degradation products are shown. Figure 2 depicts HPLC chromatograms of 5 % (w / v) lifitegrast compositions (A), (B), and (C) as described in Example 6, after photolytic stress. Major degradation product peaks are shown for (A) at relative retention time (RRT) 0.88; for (B) at RRT 0.73, RRT 0.88. For (C), no major degradation products are shown. Figure 3 depicts HPLC-chromatograms of 5 %(w / v) lifitegrast composition (C), derived from chiral HPLC as described in Example 7. Chromatographs labelled (a), (b), (c), (d), (e), (f), (g) and (h) are chiral HPLC chromatograms respectively of composition (C) having been subjected to: (a) dark (control for photolytic stress); (b) photolytic stress (200W); (c) room temperature (RT) control; (d) thermal stress, 2-8°C; (e) thermal stress, 80°C; (f) acidic stress, 80 °C; (g) basic stress 80 °C; and (h) oxidative stress, 80 °C. No peaks for lifitegrast-(R)-isomer (which should be found at RRT 5.03), or degradation products were detected under these stress conditions. The disclosure further comprises the following items 1 to 54, comprising: 1. A pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, dissolved or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof. 2. The composition according to item 1, wherein the semifluorinated alkane is selected from the group consisting of F4H5 (1-perfluorobutyl-pentane), F6H8 (1- perfluorohexyl-octane), their structural isomers and any combinations thereof. 3. The composition according to item 2, wherein the semifluorinated alkane is a combination of F4H5 (1-perfluorobutyl-pentane) and 2-perfluorobutyl-pentane. 4. The composition according to item 2, wherein the semifluorinated alkane is a combination of F6H8 (1-perfluorohexyl-octane) and 2-perfluorohexyl-octane. 5. The composition according to item 3, wherein the vehicle comprises 1- perfluorobutyl-pentane, and optionally 2-perfluorobutyl-pentane, wherein the 2- perfluorobutyl-pentane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w) or up to 0.2 % (w / w in respect of the total weight of the mixture of the semifluorinated alkanes. 6. The composition according to item 4, wherein the vehicle comprises 1- perfluorohexyl-octane, and optionally 2-perfluorohexyl-octane, wherein the 2- perfluorohexyl-octane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), up to 0.5 % (w / w), or up to 0.2 % (w / w) in respect of the total weight of the combination of the semifluorinated alkanes. The pharmaceutical composition according to items 1 to 6, wherein the vehicle consists of the semifluorinated alkane, or the combination of semifluorinated alkanes. The composition according to items 1 to 7, wherein the semifluorinated alkane or semifluorinated alkanes is / are present in an amount of at least 90%, 95%, 96%, 97%, 98%, 99% (w / w), based on the total weight of the composition. The composition according to items 1 to 8, wherein the semifluorinated alkane is 1- perfluorobutyl-pentane (F4H5) and optionally also 2-perfluorobutyl-pentane, and the semifluorinated alkane(s) is / are present in an amount of at least 90%, 95%, 96%, 97%, 98%, 99% (w / w), based on the total weight of the composition. The composition according to items 1 to 8, wherein the semifluorinated alkane is 1- perfluorohexyl-octane (F6H8), and optionally also 2-perfluorohexyl-octane and the semifluorinated alkane(s) is / are present in an amount of at least 90%, 95%, 96%, 97%, 98%, 99% (w / w), based on the total weight of the composition. The composition according to any preceding item wherein the vehicle comprises or consists of the semifluorinated alkane and one or more excipients, wherein the one or more excipients is selected from: a) a co-solvent, optionally wherein the co-solvent is an alcohol; preferably wherein the alcohol is selected from ethanol, 1-propanol, isopropanol, and phenylethyl alcohol; or more preferably wherein the alcohol is selected from ethanol and phenylethyl alcohol; b) an oily excipient, optionally wherein the oily excipient is selected from triglycerides, mineral oil, and liquid paraffin; preferably, wherein the oily excipient is selected from medium chain triglycerides (MCT) and light liquid paraffin; and c) any combination of a co-solvent or oily excipient as defined in a) or b). The composition according to any preceding item, wherein the vehicle consists of a semifluorinated alkane, and optionally a structural isomer thereof, and one or more excipients, wherein the one or more excipient is not an alcohol. The composition according to any preceding item, wherein the composition comprises an enantiomeric mixture of lifitegrast and its enantiomer (lifitegrast (R)- isomer), wherein the enantiomeric ratio of lifitegrast to its enantiomer is not 50:50. The composition according to any preceding item, wherein the composition comprises at least 80% lifitegrast or at least 90% lifitegrast, or at least 95% lifitegrast, or at least 97% lifitegrast, or at least 98% lifitegrast, or at least 99% lifitegrast, based on the total amount of lifitegrast and its enantiomer (lifitegrast (R)-isomer) in the composition. The composition according to any preceding item, wherein the composition comprises less than 10% of the lifitegrast enantiomer (lifitegrast (R)-isomer) or less than 5% of the lifitegrast enantiomer (lifitegrast (R)-isomer), or less than 2% of the lifitegrast enantiomer (lifitegrast (R)-isomer), or less than 1% of the lifitegrast enantiomer (lifitegrast (R)-isomer), or less than 0.5% of the lifitegrast enantiomer (lifitegrast (R)-isomer), based on the total amount of lifitegrast and its enantiomer (lifitegrast (R)-isomer) in the composition. The composition according to any preceding item, comprising lifitegrast in at least about 78%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 93%, 96%, 97%, 98%, 99%, or 99.5% enantiomeric excess. The composition according to any preceding item, wherein the enantiomeric ratio of lifitegrast to its enantiomer (lifitegrast (R)-isomer) in the composition is at least 89:11, 90:10, 91:8, 91:9, 92:8, 93:7, 94:6, 95:596:4, 97:3, 98:2, 99:1, 99.5:0.5, 99.7:0.3, 99.8:0.2, or at least 99.9:0.1. The pharmaceutical composition according to any preceding item comprising lifitegrast, wherein the composition comprises essentially no more than about 0.0001 to 0.001 %(w / v), or 0.004 to 0.006% (w / v) % of its enantiomer. The pharmaceutical composition according to any preceding item, wherein the composition is substantially free of the enantiomer of lifitegrast. The composition according to any preceding item, wherein lifitegrast is present in the composition at a concentration of between 2 to 8 % (w / v), or between 3 to 7 % (w / v), or between 4 to 6 % (w / v), or about 5 % (w / v). The composition according to any preceding item, wherein the one or more excipients is present, optionally independently, in an amount of up to 0.1 %, 0.5 wt%, 0.75 wt%, 1.0 wt%, 1.25 wt%, 1.4 wt%, 1.5 wt%, 1.8 wt%, 2.0 wt%, 3.0 wt%, 4.0 wt% or up to 5.0 wt% (w / w), preferably up to 1 wt% or up to 1.4 wt%, based on the total weight of the composition. The composition according to any preceding item, wherein the composition is essentially free of a) water; or b) a preservative; or c) an antioxidant; d) a surfactant and / or e) any combination of a), b), c) and d). The composition according to any preceding item, wherein the composition is a suspension of lifitegrast in the semifluorinated alkane or mixture of semifluorinated alkanes, and wherein the composition comprises or consists of: a) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane; b) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane selected from the group consisting of F4H5, F6H8, their structural isomers, and any combinations thereof; c) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane, wherein the semifluorinated alkane is 1-perfluorobutyl-pentane optionally in combination with 2-perfluorobutyl- pentane, wherein the 2-perfluorobutyl-pentane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 %, or up to 0.2 % (w / w) in respect of the total weight of the combination of the semifluorinated alkanes; or d) 2 to 8 % (w / v), or 3 to 7 % (w / v), or 4 to 6 % (w / v) or about 5 %(w / v) of lifitegrast suspended in the semifluorinated alkane, wherein the semifluorinated alkane is 1-perfluorohexyl-octane, optionally in combination with 2-perfluorohexyl- octane, wherein the 2-perfluorohexyl-octane is present in an amount of up to 2 % (w / w), or up to 1 % (w / w), or up to 0.5 % (w / w), or up to 0.2 % (w / w) in respect of the total weight of the combination of the semifluorinated alkanes. The composition according to any preceding item, wherein the amount of lifitegrast after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months in the composition is at least 90%, or at least 95%, or at least 97%, or at least 98% or at least 99% relative to the initial amount of lifitegrast in the composition. The composition according to any preceding item, wherein the enantiomeric excess of lifitegrast to its enantiomer (lifitegrast (R)-isomer) in the composition after storage at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, 12 months is at least 90%, or at least 95% or at least 99% relative to the initial enantiomeric excess of lifitegrast in the composition. The pharmaceutical composition according to any preceding item, wherein the composition is a suspension of solid particles comprising, or consisting of lifitegrast suspended in the liquid vehicle and / or the liquid semifluorinated alkane; preferably wherein the composition is a topically administered ophthalmic suspension. The pharmaceutical composition according to items 1 to 26, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol% in respect of the total volume of the composition. The pharmaceutical composition according to any preceding item, wherein the composition is formulated or adapted for topical administration to a surface of the eye, e.g. the conjunctiva and / or the cornea. The pharmaceutical composition according to any preceding item, wherein the vehicle comprises an aqueous phase (or water). The pharmaceutical composition according to item 29, wherein the lifitegrast is dissolved in the aqueous phase of the vehicle. The pharmaceutical composition according to items 29 to 30, wherein the composition is in form of an emulsion, preferably selected from an o / w-emulsion or an w / o-emulsion. The pharmaceutical composition according to items 29 to 31, wherein the vehicle comprises 30 to 70 vol%, or 40-60 vol% of the semifluorinated alkane with respect to the total volume of the vehicle, or wherein the vehicle comprises 30 to 70 wt %, or 40 to 60 wt % of the semifluorinated alkane with respect to the total weight of the vehicle. The pharmaceutical composition according to items 29 to 32, wherein the vehicle comprises 30 to 70 vol %, or 40-60 vol % of the aqueous phase with respect to the total volume of the vehicle, or wherein the vehicle comprises 30 to 70 wt %, or 40 to 60 wt % of the aqueous phase with respect to the total weight of the vehicle. The pharmaceutical composition according to items 29 to 33, wherein the aqueous phase comprises one or more components selected from: i.) a surfactant, e.g. polysorbate 80, and polysorbate 20; ii.) a buffer salts, e.g. a phosphate, citrate, borate, Tris-HCl (Tris), e.g. wherein the buffer salt is a phosphate salt, e.g. selected from sodium phosphate dibasic pentahydrate, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous; iii.) a preservative, e.g. benzalkonium chloride, polyquaternium 1 (polyquad), sodium perborate, or a preservative complex e.g. Purite®, SofZia®. The pharmaceutical composition according to items 29 to 34, wherein the vehicle comprises a surfactant in an amount of 3 to 5 wt % in respect to the total weight of the semifluorinated alkanes in the vehicle. The pharmaceutical composition according to items 29 to 35, wherein the vehicle comprises i.) 3 to 5 wt% of polysorbate 80, or ii.) 3 to 4 wt% of polysorbate 20, in respect to the total weight of the semifluorinated alkanes in the vehicle. The pharmaceutical composition according to any preceding item for use as a medicine. The composition for use according to item 37, for use in: a) the treatment, prevention or reduction of dry eye disease; or b) the treatment, prevention or reduction of signs or symptoms of dry eye disease; or c) the treatment, prevention or reduction of an ocular surface disease, preferably an ocular surface disease affecting the cornea and / or the conjunctiva, or an ocular surface disease associated with inflammation of the cornea and / or conjunctiva; or d) increasing tear production in at least one or both eyes of a subject suffering from dry eye disease; or e) the treatment of an autoimmune disorder of the ocular surface. The composition for use according to item 38, wherein the signs of dry eye disease comprise damage of the corneal surface, damage of the conjunctival surface, inflammation of the corneal surface, inflammation of the conjunctival surface, decreased tear production and any combinations thereof, and wherein the symptoms of dry eye disease comprise dry, scratchy, gritty, or sandy feeling in the eye; foreign body sensation; pain or soreness; stinging or burning; itching; increased blinking; eye fatigue; photophobia; blurry vision; redness; mucus discharge; contact lens intolerance; excessive reflex tearing, or any combinations thereof. The composition for use according to items 37 to 39 for use in the treatment of a mammalian subject, preferably a human subject. The composition for use according to items 37 to 40 for use in the treatment of a human subject, wherein the composition is topically administered daily to an eye of the subject so as to provide a daily dose of about 0.80 to 1.20 mg of lifitegrast, or of about 0.90 to 1.10 mg or of about 1.0 mg of lifitegrast per eye, optionally wherein the composition is topically administered twice daily at a single dose of about 0.40 to 0.60 mg, or of about 0.45 to 0.55 mg or of about 0.50 mg of lifitegrast per eye. A kit comprising a composition according to any preceding item, the kit comprising a container adapted for holding the composition and optionally a means for dispensing the composition and / or instructions for use. The kit according to item 42, wherein the means for dispensing is adapted for the instillation of single drops of about 9 to 12 µl volume of the composition to an eye of the subject. A method for the preparation of a composition as defined in items 1 to 28, the method comprising a step of dissolving or suspending lifitegrast in a non-aqueous vehicle comprising, or consisting of a semifluorinated alkane, and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers and any combination thereof. A method for the preparation of a composition as defined in items 29 to 36, the method comprising a step of dissolving lifitegrast in an aqueous phase, the aqueous medium optionally comprising one or more excipients and combining said aqueous phase with a liquid phase comprising, or consisting of a semifluorinated alkane, and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers and any combination thereof. A method for stabilizing lifitegrast in a composition, the method comprising a step of dissolving or suspending lifitegrast in a semifluorinated alkane as defined in any of the above items, or a step of dissolving or suspending lifitegrast in a vehicle comprising a semifluorinated alkane, and optionally one or more excipients as defined in any of the above items. A method according to items 44, 45 or 46, wherein the lifitegrast has an enantiomeric excess of at least 80 % ee, at least 90 %, at least 95 % ee or at least 97% ee, or a purity of at least 90% or at least 95% or at least 97%, or at least 99% (e.g. by HPLC). The method according to items 44 to 47 wherein the method provides for: - a prevention of, or a reduction in the rate of degradation (e.g. hydrolysis and / or dehydration and / or oxidation) of lifitegrast in the composition; and / or - a prevention of, or reduction in the rate of isomerization (e.g. racemization) of lifitegrast in the composition; and / or - a prevention of, or reduction in the enantiomeric excess of the lifitegrast in the composition; and / or - a prevention of, or reduction in the rate of formation of the lifitegrast enantiomer (lifitegrast (R)-isomer) in the composition; and / or - a prevention or reduction in the rate of formation of lifitegrast degradation products, preferably a prevention or reduction in the rate of formation of lifitegrast degradation products formed from exposure to any one or combination of thermal, oxidative, photolytic, basic or acidic conditions. The method according to items 44, 46 to 48, the method comprising a step of suspending lifitegrast in a vehicle comprising or consisting of at least 90, 93, 95, 96, 97 ,98, 99 or at least 99.5 wt% of F6H8 (1-perfluorohexyl-octane), and optionally up to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2 or up to 3 wt% of 2-perfluorohexyl- octane. The method according to items 44, 46 to 49, wherein the method is effective in reducing the amount of lifitegrast degradation product(s) to less than 10%, 8%, 6 %, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25% or less than 0.1% relative to the initial mount of lifitegrast in the composition. The method according to items 44, 46 to 50, wherein the method is effective in retaining the amount of lifitegrast after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months, in the composition at least at an amount of 90%, or at least 95%, or at least 97%, or at least 98%, or at least 99% relative to the initial amount of lifitegrast in the composition. 52. The composition according to item 1 to 36, comprising less than 10%, 8%, 6 %, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.25% or less than 0.1% of lifitegrast degradation products, relative to the initial mount of lifitegrast in the composition. 53. The composition according to item 52, wherein the degradation products of lifitegrast are formed from exposure of the composition to one or more of thermal, oxidative, photolytic, basic or acidic conditions, preferably wherein the degradation products of lifitegrast are formed from exposure to thermal, oxidative or photolytic conditions; more preferably wherein the degradation products of lifitegrast are formed from exposure to oxidative conditions. 54. The composition according to item 1 to 36, wherein the amount of lifitegrast after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months in the composition is at least 90%, or at least 95% or at least 97%, or at least 98% or at least 99% relative to the initial amount of lifitegrast in the composition, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol% in respect of the total volume of the composition. The disclosure further comprises the following items 1 to 15, comprising: 1. A pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, dissolved or suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof. 2. A method for stabilizing lifitegrast or a pharmaceutically acceptable salt thereof in a pharmaceutical composition, the method comprising a step of dissolving or suspending lifitegrast in a semifluorinated alkane or in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof. 3. The pharmaceutical composition according to items 1 or 2, wherein the semifluorinated alkane is selected from the group consisting of F4H5 (1- perfluorobutyl-pentane), F6H8 (1-perfluorohexyl-octane), their structural isomers and any combinations thereof. The pharmaceutical composition according to items 1 to 3, wherein the vehicle consists of the semifluorinated alkane, or the combination of semifluorinated alkanes. The pharmaceutical composition according to any preceding item, wherein lifitegrast is present in the composition at a concentration of between 2 to 8 % (w / v). The pharmaceutical composition according to any preceding item, wherein the composition is essentially free of a) water; or b) a preservative; or c) an antioxidant; d) a surfactant and / or e) any combination of a), b), c) and d). The pharmaceutical composition according to any preceding item, wherein the amount of lifitegrast after storage of the composition at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, or 12 months in the composition is at least 90%, or at least 95% or at least 99% relative to the initial amount of lifitegrast in the composition. The pharmaceutical composition according to any preceding item, wherein the enantiomeric excess of lifitegrast to its enantiomer (lifitegrast (R)-isomer) in the composition after storage at 0 to 60°C, e.g. storage at 25 °C for at least 1, 2, 3, 4, 5, 6, 9, 12 months is at least 90%, or at least 95% or at least 99% relative to the initial enantiomeric excess of lifitegrast in the composition. The pharmaceutical composition according to any preceding item, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol%. The pharmaceutical composition according to any preceding item, wherein the composition is formulated or adapted for topical administration to a surface of the eye, e.g. the conjunctiva and / or the cornea. The pharmaceutical composition according to any preceding item, wherein the vehicle comprises an aqueous phase, wherein the lifitegrast is dissolved in the aqueous phase of the vehicle. The pharmaceutical composition according to item 11, wherein the composition is in form of an emulsion. The pharmaceutical composition according to items 11 or 12, wherein the vehicle comprises a surfactant in an amount of 3 to 5 wt % in respect to the total weight of the semifluorinated alkane(s) in the vehicle, optionally wherein the vehicle comprises 3 to 5 wt% polysorbate 80, or 3 to 4 wt % polysorbate 20 with respect to the total weight of the semifluorinated alkane(s) in the vehicle. 14. The pharmaceutical composition according to items 1 to 10, wherein the composition consists of 5 % (w / v) lifitegrast suspended in a vehicle consisting of F6H8, and optionally one or more excipients. 15. The pharmaceutical composition according to any preceding item for use as a medicine; optionally where the composition is used for: a) the treatment, prevention or reduction of dry eye disease; or b) the treatment, prevention or reduction of signs or symptoms of dry eye disease; or c) increasing tear production in at least one or both eyes of a subject suffering from dry eye disease. The following examples serve to illustrate the invention, however, should not be understood as restricting the scope of the invention. EXAMPLES Example^1: Preparation of ophthalmic suspension compositions comprising lifitegrast and a semifluorinated alkane To prepare a 5 % (w / v) composition of lifitegrast in F6H8 or in F4H5, 50 mg of lifitegrast was weighed into a clear glass crimp vial, to which 1 ml of F6H8 (or F4H5) were added. Afterwards, a Teflon covered magnetic stir-bar was added to the vials, which were subsequently closed by crimping and placed on a magnetic stirrer set at 500 rpm for 2 hours. Both formulations of lifitegrast in F6H8, and in F4H5 respectively presented on visual inspection with a surprisingly uniform distribution of the suspended lifitegrast particles in the semifluorinated alkane. The two formulations were stored overnight. A visual inspection on the following day showed that the vast majority of API particles were still free floating and suspended in the semifluorinated alkane. A slightly shaking of the suspension formulations led to a uniform redistribution and redispersing of the lifitegrast particles, and no caking or aggregation of particles was observed. After 2, 4, 6, 8 weeks, visual inspection of the compositions still demonstrated that the compositions remained unchanged; both of the suspension compositions remained easily redispersible. Similar studies were performed for the suspension compositions with lifitegrast concentrations ranging from 10 to 90 mg / mL, i.e.1 to 9% (w / v) lifitegrast suspensions in F6H8, or in F4H5. Suspension formulations consisting of 10 mg / ml, 25 mg / ml, 30 mg / ml, 70 mg / ml and 90 mg / ml lifitegrast suspended in F6H8 or in F4H5 were prepared. All formulations in the said concentration range exhibited the same visual physical characteristics as described above. Example^2: Preparation of the ophthalmic compositions comprising lifitegrast, a semifluorinated alkane and excipients Following the procedure described in Example 1, the following formulations were prepared: - 10, 25, 30, 50, 70 and 90 mg / ml lifitegrast, suspended in a vehicle comprising F6H8 and 1 wt% ethanol Example^3: Determining the oxygen content of a composition comprising lifitegrast The oxygen content of a suspension formulation of 50 mg / mL lifitegrast in F6H8 shortly after its preparation was performed and compared against the oxygen content of only the vehicle, F6H8. The oxygen content of the formulation was determined using a chemical optical oxygen microsensor (PreSens—Precision Sensing GmbH; Regensburg, Germany, the measurement range of the microsensor is 0-250% air saturation, translating to 0-22.5 mg / L dissolved oxygen). No difference in the measurements of oxygen content between the F6H8 vehicle and the composition of lifitegrast / F6H8 (50 mg / mL) could be observed. Both measurements gave the same value of 22% oxygen saturation what converts to approx.4.61 vol % oxygen (or 1.9 mg / ml). Example^4: Preparation of ophthalmic emulsion compositions comprising lifitegrast and a semifluorinated alkane The ophthalmic emulsion compositions were prepared according to the following procedure: First, the respective amounts of lifitegrast and the surfactant were mixed in the aqueous buffer, to form the aqueous phase. Afterwards the semifluorinated -phase was slowly added to the aqueous phase under vigorous stirring. This pre-emulsion was stirred at 2000 rounds / min for over 1 hour. The turbid pre-emulsion was then sonicated (UP400S, Hielscher) for 5 min with maximum amplitude under ice bath cooling, resulting in the emulsion. The prepared emulsions present as physically stable upon visual inspection. Following this general procedure the following emulsion compositions were prepared: Semifluorinated^alkane^ Surfactant Aqueous^phase phase (wt^%^with^respect^to^ (wt^%^with^respect^to^the^ total^weight^of^the^ total^weight^of^the^ composition) composition) F6H8, 40 wt % Tween 80, 1.6 wt % (4 wt %*) 5 wt% lifitegrast dissolved in PBS-buffer F6H8, 40 wt % Tween 80, 1.2 wt % (3 wt %*) 2.5 wt% lifitegrast dissolved in PBS-buffer F6H8, 40 wt % Tween 20, 1.2 wt % (3 wt%*) 5 wt% lifitegrast dissolved in PBS-buffer F6H8, 60 wt % Tween 80, 2.4 wt% (4 wt%*) 5 wt% lifitegrast dissolved in PBS-buffer F6H8, 50 wt % Tween 80, 2.0 wt % (4 wt%*)5 wt% lifitegrast dissolved inPBS-buffer F4H5, 50 wt % Tween 80, 2.0 wt % (4 wt%*) 5 wt% lifitegrast dissolved in PBS-buffer Note: *=concentration in respect to the total weight of the semifluorinated alkane phase (total weight of the semifluorinated alkane(s) in the composition). Example^5: Stability of ophthalmic suspension compositions comprising lifitegrast and a semifluorinated alkane Forced degradation and stress studies were performed to establish the stability of ophthalmic suspension compositions comprising lifitegrast and a semifluorinated alkane. A 5% lifitegrast suspension in F6H8 was subjected to thermal, oxidative, acidic, and basic stress, each carried out at 80°C for 24 hours. Furthermore, photolytic stress (1.2 million luxvisible light and 200 wh / m2 UV light) was conducted at room temperature. The stressed samples were analyzed by UV (260 nm) and by reverse phase HPLC (C18 column, mobile phase A: phosphoric acid dilution, mobile phase B: acetonitrile with phosphoric acid, gradient system, flow 0.8 mL / min, 40°C column temperature, UV-detection at 210 nm, 260 nm). From these studies, it was observed that the composition comprising lifitegrast suspended in F6H8 is highly stable. No prominent degradation products were identified, which is surprising considering the harsh stress condition at 80°C for 24 hours. Remarkably, the suspension of lifitegrast in F6H8 did not reveal degradation under thermal stress, which - when considering the high oxygen saturation of ~22% (see Example 3) of the formulation - includes already oxidative stress. And even further, when additional oxidative stress was applied, no oxidative degradation was observed. This was unexpected and in contrast to the prior art teaching that aqueous lifitegrast formulation is sensitive to oxidation (leading to inclusion of an antioxidant in commercial aqueous lifitegrast ophthalmic compositions). Therefore, semifluorinated alkanes as vehicle not only supports overall stability, but also eliminates the necessity of an antioxidant. Example^6: Stability & Degradation Products To further investigate the stability of ophthalmic suspension compositions comprising lifitegrast a comparison to aqueous solution formulations of lifitegrast was conducted. Following the setup of the forced degradation and stress studies described in Example 5 the following three lifitegrast compositions were compared: (A) 5 % (w / v) lifitegrast, dissolved in 10 mM phosphate buffer, pH 9.2 [aqueous]; (B) 5 % (w / v) lifitegrast commercial ophthalmic solution (Xiidra®), dissolved phosphate buffer pH 7-8, containing sodium thiosulfate as antioxidant [aqueous]; (C) 5 % (w / v) lifitegrast, suspended in 1-perfluorohexyloctane [non-aqueous]. The lifitegrast samples (A), (B), (C) that were subjected to thermal, photolytic, oxidative and basic stress conditions and were analysed based on the HPLC-analytical method as described in Example 5, and the peak areas of lifitegrast and its major degradation products were quantified (see Figures 1 and 2). Under basic stress conditions, a major degradation product at relative retention time (RRT) 0.67 with a relative total peak area of 1.38% was found only for composition (A). When subjected to thermal stress conditions, no major degradation products were identified for lifitegrast samples (B), (C), while one major degradation product at RRT 0.67 with a relative total peak area of 3.48% was observed for aqueous formulation (A). Instead, major differences were observed under oxidative and photolytic conditions between the three formulations (see Table 1 below). Under oxidative stress, for composition (A) a major degradation product at relative retention time (RRT) 0.67 with a relative total peak area of 2.39% was found, with additional impurities appearing between RTT 0.67-0.88. The commercial 5 % lifitegrast ophthalmic solution Xiidra®(B) showed major degradation products at RRT 0.42, RRT 0.60 and RRT 0.73, amounting to a relative total peak area of 6.48%. In comparison, the non-aqueous suspension of lifitegrast in F6H8 (C) did not show major degradation products and was found to be stable to the oxidative stress conditions. Subjecting the samples to photolytic stress, for composition (A) an impurity at RRT 0.88 with a relative total peak area of 1.38% was detected, along with further impurities. The commercial lifitegrast ophthalmic solution Xiidra®(B) showed two major degradation products at RRT 0.73 (7.03 min) and RRT 0.88 (8.48 min), amounting to a relative total peak area of 1.41%. More impurities were noted between RRT 0.40-0.56 (3.8-4.5 min). The non- aqueous suspension of lifitegrast in F6H8 (C) was found to be stable to the photolytic stress, with no major degradation products detected. In summary, the findings of Example 5 were confirmed, revealing that lifitegrast suspended in a semifluorinated alkane (F6H8) (C) was more stable under the applied stress condition when compared to both aqueous lifitegrast formulations (A), (B). This is in particular surprising for oxidative stress, when considering that the commercial Xiidra®formulation (B) already contains an antioxidant (sodium thiosulfate) that should prevent, or at least reduce, oxidation of the active ingredient lifitegrast. And the difference observed for stability against oxidative stress with respect to the non-aqueous lifitegrast suspension in SFA (C) compared to the aqueous formulations is even more surprising, when its high oxygen saturation of ~22% (see Example 3) is taken in account. This underlines the advantages with regard to the stability of lifitegrast against oxidative stress and other environmental stress conditions as noted herein, when formulated e.g. suspended in a semifluorinated alkane, such as 1- perfluorohexyloctane. Table 1 Major^Degradation^Products relative total peak area, % stress^ (A) (B) (C) condition 5% (w / v) lifitegrast,^ 5% (w / v) lifitegrast,^ 5% (w / v) lifitegrast,^ aqueous^buffer aqueous^commercial^ suspension^in^F6H8^ (Xiidra®) oxidative stress 2.39% 6.48% no major degradation (RRT 0.67) (RRT 0.42, RRT 0.60, products observed RRT 0.73) photolytic 1.38% 1.41% no major degradation stress (RRT 0.88) (RRT 0.73, RRT 0.88) products observed basic stress 3.80% no major degradation no major degradation (RRT 0.67) products observed products observed Major^Degradation^Products relative total peak area, % stress^ (A) (B) (C) condition 5% (w / v) lifitegrast,^ 5% (w / v) lifitegrast,^ 5% (w / v) lifitegrast,^ aqueous^buffer aqueous^commercial^ suspension^in^F6H8^ (Xiidra®) thermal stress 3.48% no major degradation no major degradation (RRT 0.67) products observed products observed RRT = Relative Retention Time (retention time determined in relation to lifitegrast) Example^7 The forced degradation and stress studies described in Example 5 were repeated for compositions (B) and (C) and analyzed by chiral HPLC (Chiralcel OJ-RH column, mobile phase A: formic acid, pH 3.0, mobile phase B: acetonitrile; isocratic (65:35), flow 1.0 mL / min, 40°C column temperature, UV-detection at 260 nm). This analysis confirmed the findings of Example 6, that under oxidative stress conditions higher occurrence of conversion of lifitegrast to degradation products were observed for the commercial Xiidra® formulation (B), while the non-aqueous suspension of lifitegrast in F6H8 (C) was found to be stable, with no detection of major degradation products. Moreover, no conversion of lifitegrast to its enantiomer (lifitegrast (R)-isomer) was observed for the non-aqueous suspension of lifitegrast in F6H8 (C) even under the applied forced degradation and stress conditions, demonstrating that the optical purity and enantiomeric excess (ee) of lifitegrast in this formulation remains stable and is preserved (Figure 3).

Claims

NVL23P02PC1 Claims 1. A pharmaceutical composition comprising lifitegrast or a pharmaceutically acceptable salt thereof, suspended in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof.

2. The pharmaceutical composition according to claim 1, wherein the semifluorinated alkane is selected from the group consisting of F4H5 (1-perfluorobutyl-pentane), F6H8 (1-perfluorohexyl-octane), their structural isomers and any combinations thereof.

3. The pharmaceutical composition according to claims 1 or 2, wherein the vehicle consists of the semifluorinated alkane, or a combination of semifluorinated alkanes.

4. The pharmaceutical composition according to any preceding claim, wherein lifitegrast is present in the composition at a concentration of between 2 to 8 % (w / v).

5. The pharmaceutical composition according to any preceding claim, wherein the composition is essentially free of a) water; or b) a preservative; or c) an antioxidant; d) a surfactant and / or e) any combination of a), b), c) and d).

6. The pharmaceutical composition according to any preceding claim, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol%.

7. The pharmaceutical composition according to any preceding claim, wherein the composition is formulated or adapted for topical administration to a surface of the eye, e.g. the conjunctiva and / or the cornea.

8. The pharmaceutical composition according to any preceding claim, wherein the composition consists of 5 % (w / v) lifitegrast suspended in a vehicle consisting of F6H8 and optionally one or more excipients.

9. The pharmaceutical composition according to any preceding claim for use as a medicine.

10. The pharmaceutical composition for use according to claim 9, wherein the composition is for use in: a) the treatment, prevention or reduction of dry eye disease; or b) the treatment, prevention or reduction of signs or symptoms of dry eye disease;or c) increasing tear production in at least one or both eyes of a subject suffering from dry eye disease.

11. A method for stabilizing lifitegrast or a pharmaceutically acceptable salt thereof in a pharmaceutical composition, the method comprising a step of suspending lifitegrast in a semifluorinated alkane, or in a vehicle comprising a semifluorinated alkane and optionally one or more excipients, wherein the semifluorinated alkane is selected from the group consisting of F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, F6H10, or their structural isomers, and any combinations thereof.

12. The method according to claim 11, wherein the semifluorinated alkane is selected from the group consisting of F4H5 (1-perfluorobutyl-pentane), F6H8 (1- perfluorohexyl-octane), their structural isomers and any combinations thereof.

13. The method according to claim 11 or 12, wherein the vehicle consists of the semifluorinated alkane, or the combination of semifluorinated alkanes.

14. The method according to any one of claims 11 to 13, wherein lifitegrast is present in the composition at a concentration of between 2 to 8 % (w / v).

15. The method according to any one of claims 11 to 14, wherein the vehicle is essentially free of a) water; or b) a preservative; or c) an antioxidant; d) a surfactant and / or e) any combination of a), b), c) and d).

16. The method according to any one of claims 11 to 15, wherein the oxygen content in the composition is not less than 3 vol%, 4 vol%, 5 vol%, 6 vol%, 7 vol% or not less than 8 vol%.

17. The method according to any of claims 11 to 16 wherein the method comprises suspending 5 % (w / v) lifitegrast in a vehicle consisting of F6H8 and optionally one or more excipients.

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